FDA product code PFG: Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
PFG is the FDA product code for dna fish probe kit for specimen characterization, human chromosome, hematological disorders. It is a Class II device, regulated under 21 CFR 864.1870 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PFG. The average 510(k) review took 112 days (median 112).
Definition
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Classification
| Field | Value |
|---|---|
| Device name | Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders |
| Device class | Class II |
| Regulation | 21 CFR 864.1870 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PFG clearance
Top PFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 2013-09-13 |
Most recent PFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131508 | Abbott Molecular, Inc. | VYSIS D7S486/CEP 7 FISH PROBE KIT | 2013-09-13 | 112 |
Recalls for PFG devices
openFDA lists no recalls for product code PFG.
Frequently asked questions
What is FDA product code PFG?
PFG is the FDA product code for dna fish probe kit for specimen characterization, human chromosome, hematological disorders. It is a Class II device, regulated under 21 CFR 864.1870 and reviewed by the Pathology panel.
What device class is PFG?
Class II, regulation 21 CFR 864.1870. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFG?
Across 1 cleared submissions the average was 112 days from receipt to decision (median 112).
Which companies have the most PFG clearances?
Abbott Molecular, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFG
- Run a recall and safety report across every PFG manufacturer
- Watch product code PFG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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